Intra-articular Injections for Shoulder Osteoarthritis
(GHOA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rush University Medical Center
Disqualifiers: Rheumatoid arthritis, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The purpose of this study is to compare the efficacy of intra-articular corticosteroid injections versus platelet-rich plasma injections for non-operative treatment of primary glenohumeral osteoarthritis. The efficacy of intra-articular injections, outside of hyaluronic acid, for the treatment of glenohumeral OA is not known, yet these treatments are commonly used with hopes of providing patients with symptomatic relief that can hopefully delay or prevent the need for shoulder arthroplasty. This study will help elucidate the therapeutic benefit of corticosteroid and Platelet Rich Plasma (PRP) injections in this patient population.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Intra-articular Injections for Shoulder Osteoarthritis?
Research shows that platelet-rich plasma (PRP) injections can reduce pain and improve joint function in knee osteoarthritis, and have beneficial effects in managing joint degenerative conditions. Additionally, corticosteroid injections are used to treat shoulder pain, suggesting potential benefits for shoulder osteoarthritis.12345
Is it safe to use intra-articular injections for shoulder osteoarthritis?
How does the treatment of intra-articular injections for shoulder osteoarthritis differ from other treatments?
Intra-articular injections for shoulder osteoarthritis, such as corticosteroid and platelet-rich plasma (PRP) injections, are unique because they are directly administered into the joint, providing targeted relief. PRP injections are particularly novel as they use components from the patient's own blood to promote healing and reduce inflammation, offering a natural alternative to traditional steroid injections.12389
Research Team
Eligibility Criteria
This trial is for adults over 18 with primary glenohumeral osteoarthritis, which means they have significant shoulder joint pain and damage seen on X-rays. They must be experiencing a baseline pain level of more than moderate intensity. People who've had recent shoulder surgery, are pregnant, involved in workers' compensation cases for the shoulder, or have other types of arthritis or allergies to lidocaine can't participate.Inclusion Criteria
My pain level is more than 4 on a scale of 0-10.
I am 18 years old or older.
I have been diagnosed with shoulder arthritis through X-rays and doctor's exams.
Exclusion Criteria
Known pregnancy
I haven't had a shoulder joint injection in the last 3 months.
My arthritis is not caused by infections, injuries, or other specific conditions.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either corticosteroid or platelet-rich plasma injections for the treatment of primary glenohumeral osteoarthritis
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Intra-articular Corticosteroid Injection (Corticosteroid)
- Intra-articular Platelet-rich Plasma Injection (Platelet-rich Plasma)
Trial OverviewThe study aims to see if corticosteroid injections into the shoulder joint work better than platelet-rich plasma (PRP) injections for treating primary glenohumeral osteoarthritis without surgery. It's testing whether these treatments can relieve symptoms enough to delay or avoid shoulder replacement surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Corticosteroid Injection GroupExperimental Treatment1 Intervention
80mg Depo-Medrol and 8cc Lidocaine ultrasound-guided intra-articular injection
Group II: Platelet-Rich Plasma Injection GroupActive Control1 Intervention
15cc blood draw in Arthrex Autologous Conditioned Plasma (ACP) kit and processed per manufacturer instructions Ultrasound-guided intra-articular injection of isolated PRP
Intra-articular Corticosteroid Injection is already approved in United States, European Union, Canada, Australia for the following indications:
πΊπΈ Approved in United States as Corticosteroid Injection for:
- Osteoarthritis
- Shoulder arthritis
- Glenohumeral osteoarthritis
- Rotator cuff disease
- Adhesive capsulitis
- Acromioclavicular joint disease
πͺπΊ Approved in European Union as Corticosteroid Injection for:
- Osteoarthritis
- Shoulder arthritis
- Glenohumeral osteoarthritis
- Rotator cuff disease
- Adhesive capsulitis
- Acromioclavicular joint disease
π¨π¦ Approved in Canada as Corticosteroid Injection for:
- Osteoarthritis
- Shoulder arthritis
- Glenohumeral osteoarthritis
- Rotator cuff disease
- Adhesive capsulitis
- Acromioclavicular joint disease
π¦πΊ Approved in Australia as Corticosteroid Injection for:
- Osteoarthritis
- Shoulder arthritis
- Glenohumeral osteoarthritis
- Rotator cuff disease
- Adhesive capsulitis
- Acromioclavicular joint disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rush University Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Trials
448
Patients Recruited
247,000+
References
Single Intra-articular Platelet-Rich Plasma Versus Corticosteroid Injections in the Treatment of Adhesive Capsulitis of the Shoulder: A Cohort Study. [2020]The aim of the study was to compare the effects of single intra-articular platelet-rich plasma (PRP) and corticosteroid (CS) injections in patients with adhesive capsulitis of the shoulder.
Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial. [2022]Intra-articular injections of platelet rich plasma (PRP) for the treatment of knee osteoarthritis have been shown to reduce pain and improve joint function. The aim of this study is to examine the joint function by adding intra-articular growth hormone to platelet rich plasma. This study was performed on the individuals with knee osteoarthritis and under ultrasound guidance.
Role of Intra-articular Platelet Rich Plasma in the Management of Osteoarthritis: A Review. [2020]Intra-articular injections are a minimally invasive option developed for the management of patients with joint degenerative conditions. These injections can involve the use of steroid preparations, hyaluronic acid, and blood products. Platelet-rich plasma (PRP) is a cost-effective management modality developed for patients with joint degenerative conditions and has provided promising outcomes. It provides nourishment to the chondrocytes through a rich supply of growth factors and cytokines. This article demonstrates the beneficial effects of PRP therapy in patients with osteoarthritis.
Effects of corticosteroids and platelet-rich plasma on synoviocytes in IL-1Γ-induced inflammatory condition. [2022]Corticosteroid injections are used to treat shoulder pain. Platelet-rich plasma (PRP) is known to have anti-inflammatory and anabolic effects, as well as cytoprotective effects against corticosteroids. Thus, this study was to investigate the effects of co-treatment of corticosteroid and PRP on anti-inflammatory and matrix homeostasis of synoviocytes in IL-1Γ-induced inflammatory conditions.
Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. [2022]To evaluate the clinical effects of intraarticular platelet-rich plasma (PRP) injections in a small group of patients with primary and secondary osteoarthritis. Most of the current treatments for osteoarthritis are palliative and attack the symptoms rather than influencing the biochemical environment of the joint. Autologous platelet-rich plasma has emerged as a treatment option for tendinopathies and chronic wounds. In addition to release of growth factors, platelet-rich plasma also promotes concentrated anti-inflammatory signals including interleukin-1ra, which has been a focus of emerging treatments for osteoarthritis.
Intra-Articular Leukocyte-Poor Platelet-Rich Plasma Injections for Japanese Patients With Osteoarthritis of the Knee: A Three-Year Observational Retrospective Study After Phase 1 and Phase 2a Trials. [2022]We have previously confirmed the safety and feasibility of intra-articular (IA) platelet-rich plasma (PRP) injections in Japanese patients with osteoarthritis (OA) of the knee. This study aimed to investigate the clinical and radiological outcomes in patients who were followed up for three years.
Comparison of the Efficacy of Platelet-Rich Plasma (PRP) and Local Corticosteroid Injection in Periarthritis Shoulder: A Prospective, Randomized, Open, Blinded End-Point (PROBE) Study. [2022]Background Periarthritis or frozen shoulder, also called adhesive capsulitis, is characterized by stiffness and pain along with gradual loss of active and passive movement in the glenohumeral joint. More than 2-5% of the population suffers from periarthritis with a higher incidence in the age group of 40-60 years. The various treatment modalities used for its management include simple physiotherapy, short-wave therapy, ultrasonic therapy, transcutaneous electrical nerve stimulation, hydrotherapy, analgesics, intra-articular injections, manipulation under general anesthesia (MUA), and surgical management. The application of intra-articular steroid injection has been a common and efficacious option in rapidly diminishing shoulder pain and disability. Some recent studies reported a better outcome using platelet-rich plasma (PRP) injections in frozen shoulder cases. Hence, this randomized controlled trial was conducted to compare the efficacy of intra-articular injections of PRP and triamcinolone in patients of shoulder periarthritis in a population from the eastern region of India Methodology A total of 60 patients with periarthritis shoulder were allocated into two groups after randomization. Group A received 2 mL autologous PRP, and Group B received 2 mL of triamcinolone (40 mg/mL) intra-articular injection. Patients were followed up on the 4th week, 12th week, and 24th week. The assessment of pain and function using the visual analog scale (VAS) score and the Disabilities of Arm, Shoulder, and Hand (DASH) score, respectively, was done at each follow-up. The primary analyses of both primary and secondary outcomes were conducted in the intention-to-treat (ITT) population. SPSS version 24 (IBM Corp., Armonk, NY, USA) was used for data analysis. Results The mean VAS score in the PRP and triamcinolone groups was 14.33 Β± 3.79 and 31.63 Β± 7.62, respectively (p = 0.0001) after 24 weeks. The mean DASH score in the PRP and triamcinolone groups was 18.08 Β± 8.08 and 31.76 Β± 3.63, respectively (p = 0.0001), which shows significant improvement in both pain and disability scores in the PRP group after 24 weeks. Conclusions The triamcinolone group showed better short-term outcomes whereas PRP showed better long-term outcomes in reducing pain and disability scores in terms of VAS and DASH scores.
[Effectiveness of platelet rich plasma in pain management of osteoarthritis knee: double blind, randomized comparative study]. [2022]Intra-articular injections of platelet-rich plasma to treat symptoms of knee osteoarthritis have been successfully used in young patients. However in most of these studies the control and test knees were present in different patients thus incorporating a large amount of bias in the results. Therefore, the present study was designed in which patients with bilateral osteoarthritis knee were included and platelet-rich plasma was administered in one knee and normal saline in another knee of same patient.
Clinical Fate of Glenohumeral Osteoarthritis Following Intraarticular Corticosteroid Injection: An Analysis in 311 Shoulders. [2022]Intraarticular corticosteroid injection is commonly used conservative treatment for glenohumeral osteoarthritis (OA). The purpose of this study was to investigate the clinical fate of symptomatic glenohumeral OA following intraarticular corticosteroid injection and to identify factors associated with undergoing shoulder arthroplasty.